本文選題：醫(yī)療機構(gòu)　切入點：醫(yī)療機構(gòu)制劑　出處：《南京中醫(yī)藥大學(xué)》2014年碩士論文

【摘要】：醫(yī)療機構(gòu)制劑是我國特有的概念,其產(chǎn)生與發(fā)展的原因與我國的基本國情息息相關(guān)。在建國初期缺醫(yī)少藥的大背景下,醫(yī)療機構(gòu)制劑對維護(hù)國民健康、支持我國醫(yī)療衛(wèi)生事業(yè)發(fā)展做出的貢獻(xiàn)不容置疑。經(jīng)過建國以來60多年的發(fā)展,我國的醫(yī)藥工業(yè)已經(jīng)煥然一新,藥品供應(yīng)體系也已經(jīng)基本建立。但是醫(yī)療機構(gòu)制劑治療疾病方面仍起著不可取代的作用。在社會大眾對藥品安全性關(guān)注日益提高的大背景下,國家法律法規(guī)對其的要求也越來越嚴(yán)格,這也使得新時期我國醫(yī)療機構(gòu)制劑的發(fā)展出現(xiàn)了新特點。 本研究在闡述江蘇省醫(yī)療機構(gòu)制劑發(fā)展和監(jiān)管歷史的基礎(chǔ)上,對醫(yī)療機構(gòu)制劑配制、使用和監(jiān)管現(xiàn)狀開展定性研究和定量研究。首先,選取江蘇省具有制劑許可證的醫(yī)療機構(gòu)作為研究對象,搜集制劑配制許可證、醫(yī)療機構(gòu)制劑批準(zhǔn)文號以及醫(yī)療機構(gòu)制劑再注冊等有關(guān)材料；其次,對江蘇省醫(yī)療機構(gòu)制劑基本情況進(jìn)行調(diào)研,并對醫(yī)療機構(gòu)制劑安全性監(jiān)測現(xiàn)狀進(jìn)行專家訪談；最后,通過SWOT-PEST分析得出江蘇省醫(yī)療機構(gòu)制劑現(xiàn)狀存在問題以及監(jiān)管中的不足,并進(jìn)而提出相關(guān)的對策建議。 通過本研究可以得出目前江蘇省醫(yī)療機構(gòu)制劑的一般結(jié)果：醫(yī)療機構(gòu)制劑室數(shù)量在逐年減少,逐漸趨于合理；醫(yī)療機構(gòu)制劑批準(zhǔn)文號數(shù)量在大幅度減少,基本符合醫(yī)療機構(gòu)制劑定位；醫(yī)療機構(gòu)制劑室人員數(shù)量不足,專業(yè)素質(zhì)普遍不高；醫(yī)療機構(gòu)制劑研發(fā)資金投入少,研發(fā)水平不高；醫(yī)療機構(gòu)制劑不良反應(yīng)率逐漸降低,但不良反應(yīng)監(jiān)測和再評價仍需加強；醫(yī)療機構(gòu)中藥制劑委托加工應(yīng)加強管理；醫(yī)療機構(gòu)制劑加入醫(yī)保范圍仍需加大；醫(yī)療機構(gòu)制劑配制質(zhì)量管理規(guī)范的實施,制劑質(zhì)量與安全性得到了提高；醫(yī)療機構(gòu)制劑原料檢驗遠(yuǎn)遠(yuǎn)達(dá)不到要求；醫(yī)療機構(gòu)制劑監(jiān)督管理體系仍需完善。
[Abstract]:Medical institution preparation is a unique concept in our country, and the reasons for its emergence and development are closely related to the basic conditions of our country. In the background of lack of medical and minor medicine in the early days of the founding of the people's Republic of China, medical institution preparations have a great impact on the maintenance of national health. The contribution of supporting the development of medical and health care in our country is beyond doubt. After more than 60 years of development since the founding of the people's Republic of China, the pharmaceutical industry in our country has taken on a new look. The drug supply system has also been basically established. But medical institutions still play an irreplaceable role in the treatment of diseases. Against the background of increasing public concern about drug safety, The requirements of national laws and regulations are more and more strict, which makes the development of medical institutions in our country appear new characteristics in the new period. On the basis of expounding the history of preparation development and supervision of medical institutions in Jiangsu Province, this study carries out qualitative and quantitative studies on the present situation of preparation, use and supervision of formulations in medical institutions. Selecting the medical institutions with preparation license in Jiangsu Province as the research object, collecting the preparation license, the approval number of the preparation of the medical institution and the re-registration of the preparation of the medical institution. Secondly, To investigate the basic situation of medical institutions in Jiangsu Province, and to conduct expert interviews on the status quo of safety monitoring of medical institutions. Finally, through SWOT-PEST analysis, we can conclude that the current situation of medical institutions in Jiangsu Province has problems and deficiencies in supervision. And then put forward the relevant countermeasures and suggestions. Through this study, we can get the general results of the preparation of medical institutions in Jiangsu Province: the number of preparation rooms in medical institutions is decreasing year by year, and gradually tending to be reasonable, and the number of approved documents for medical institutions is greatly reduced. It is basically in line with the orientation of medical institutions; the number of personnel in the preparation rooms of medical institutions is insufficient, and the professional quality is generally not high; the investment in R & D of medical institutions is low, and the level of R & D is not high; the adverse reaction rate of medical institutions is gradually decreasing. However, the monitoring and re-evaluation of adverse reactions should be strengthened; the commissioning and processing of traditional Chinese medicine preparations in medical institutions should be strengthened; the scope of medical institutions' preparations added to medical insurance still need to be enlarged; and the implementation of quality management norms for the preparation of medical institutions' preparations, The quality and safety of the preparation have been improved; the raw material inspection of the preparation in medical institutions is far from meeting the requirements; the supervision and management system of the preparation in the medical institutions still needs to be improved.
【學(xué)位授予單位】：南京中醫(yī)藥大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2014
【分類號】：R95

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